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The Alere BinaxNOW® Influenza A & B Card is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab, nasal swab, and nasal wash/aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results are presumptive and should be confirmed by cell culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions.

Caution: Assay sensitivity for nasal wash/aspirate samples was determined primarily using archived specimens. Users may wish to establish the sensitivity of these specimens on fresh samples.

The Alere BinaxNOW® Influenza A & B Card is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect influenza type A and B nucleoprotein antigens in respiratory specimens. These antibodies and a control antibody are immobilized onto a membrane support as three distinct lines and combined with other reagents/pads to construct a test strip. This test strip is mounted inside a cardboard, book-shaped hinged test card.

Swab specimens require a sample preparation step, in which the sample is eluted off the swab into elution solution, saline or transport media. Nasal wash/aspirate samples require no preparation. Sample is added to the top of the test strip and the test card is closed. Test results are interpreted at 15 minutes based on the presence or absence of pink-to-purple colored Sample Lines. The blue Control Line turns pink in a valid assay.

Here's a breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

Device: Alere BinaxNOW® Influenza A & B Card

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a structured table format with specific thresholds. However, the performance summary provides quantitative results against a reference standard (Cell Culture/DFA), which implicitly serve as the criteria the device aims to meet. The implicit acceptance criteria would be for the sensitivity and specificity values to be within acceptable ranges for a rapid diagnostic test, generally aiming for high specificity to minimize false positives and reasonable sensitivity. The study results demonstrate these performance characteristics for the device.

Here's a table summarizing the reported device performance for the clinical studies, which can be interpreted as demonstrating the device meets implicit acceptance criteria for sensitivity and specificity:

Implicit Acceptance Criteria (Demonstrated Performance)

2. Sample Sizes Used for the Test Set and Data Provenance

Prospective Study:

• Sample Size: 846 specimens (nasopharyngeal and nasal swabs).
• Data Provenance: Multi-center clinical studies conducted at a central testing laboratory outside the US during the 2004 respiratory season and at three US trial sites during the 2005-2006 respiratory season.

Retrospective Study:

• Sample Size: 293 frozen clinical samples.
• Data Provenance: Clinical samples collected from symptomatic patients at multiple physician offices, clinics, and hospitals located in the Southern, Northeastern, and Midwestern regions of the United States and from one hospital in Sweden.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document refers to "Cell Culture / DFA" (Direct Fluorescent Antibody) as the comparative method for establishing ground truth. This indicates that the ground truth was established by laboratory testing using established and validated methods, rather than clinical expert consensus. Therefore, the concept of "number of experts" or their "qualifications" in the traditional sense of clinical adjudication by physicians is not directly applicable here. The experts would be the laboratory personnel performing and interpreting the cell culture and DFA, who are presumed to be qualified in these laboratory techniques.

4. Adjudication Method (for the test set)

The adjudication method used for the comparison was against Cell Culture / DFA. This means that discrepancies between the device's results and the Cell Culture / DFA results would be evaluated against the "gold standard" of Cell Culture / DFA without a specified clinical adjudication process detailed in the submission. The text does not mention a 2+1, 3+1, or similar expert adjudication process for discordant results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, the provided document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance is evaluated. The study focuses on the standalone performance of the Alere BinaxNOW® Influenza A & B Card compared to laboratory reference methods.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done

Yes, the studies presented are standalone performance studies of the Alere BinaxNOW® Influenza A & B Card. The results show the performance of the device itself (immunochromatographic assay) in detecting influenza antigens, without human interpretation being the primary variable of interest. While human operators interpret the results (presence/absence of pink-to-purple lines), the study assesses the diagnostic accuracy of the test product against the reference standard. The "Reproducibility Study" involved multiple operators interpreting cards, indicating that human interpretation is part of the device's use, but the primary clinical performance studies (sensitivity/specificity vs. Cell Culture/DFA) evaluate the device's diagnostic capability. The "Analytical Sensitivity" section involved 12 different operators interpreting cards, further indicating that the interpretation by human users is part of the device's intended use and evaluation.

7. The type of Ground Truth Used

The primary ground truth used for both prospective and retrospective clinical studies was Cell Culture / DFA (Direct Fluorescent Antibody). This is a widely accepted and established laboratory method for influenza virus detection.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" or its sample size. This is common for rapid diagnostic devices like the Alere BinaxNOW® Influenza A & B Card, which are developed based on established immunological principles and optimized through R&D, rather than being "trained" in the machine learning sense on a distinct dataset. The clinical studies described are validation studies for the finalized device.

9. How the Ground Truth for the Training Set Was Established

As noted in point 8, there is no explicit "training set" mentioned in the context of machine learning. Therefore, the establishment of ground truth for a training set is not applicable here. The device's performance was evaluated against the gold standard of Cell Culture/DFA in clinical validation studies.

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SASTM Influenza A Test is a visual and rapid assay for the presumptive in-vitro qualitative detection of influenza A viral nucleoprotein antigens from nasal washes and nasal aspirates of symptomatic patients. The test is not intended for the detection of Influenza Type B viral antigen or Influenza Type C viral antigen. This test is for professional use only.

Negative results do not preclude infection with influenza A and should not be used as the sole basis for treatment or other patient management decisions. It is recommended that negative results be confirmed by cell culture.

SASTM FluAlert A & B Test is a visual and rapid assay for the presumptive in-vitro qualitative detection of Influenza A and Influenza B viral nucleoprotein antigens from nasal washes and nasal aspirates of symptomatic patients. The test is not intended for the detection of Influenza Type C viral antigen. This test is for professional use only.

Negative results do not preclude infection with influenza A and/or influenza B and should not be used as the sole basis for treatment or other patient management decisions. It is recommended that negative results be confirmed by cell culture.

The SASTM Influenza A Test utilizes antibodies against influenza type A viral nucleoproteins. The SASTM Influenza A test begins with an extraction of Type A nucleoproteins. After the extraction has been completed, the sample is placed into the sample well of the test. The specimen is absorbed and migrates via capillary action through membranes that contain dried gold conjugated antibody, which is specific for influenza A viral nucleoproteins. If these nucleoproteins are present, a "half-sandwich" immunocomplex is formed. The membrane contains immobilized antibody to influenza A nucleoproteins, which binds the "half sandwich" complex. Thus, in the presence of influenza A nucleoproteins, a "whole sandwich" immunocomplex is formed and a visible, pink-colored line develops in the specimen zone of the test device. In the absence of an influenza A antigen, a "sandwich" immunocomplex is not formed and a negative result is indicated. To serve as a procedural control, a pink-colored control line will always appear in the control zone of each strip regardless of the presence or absence of influenza A nucleoproteins.

The SASTM FluAlert A & B Test utilizes antibodies against influenza type A and influenza type B viral nucleoproteins. After the extraction has been completed, the sample is placed into two separate sample wells. The specimen is absorbed and migrates via capillary action through membranes that contain dried gold conjugated antibody, which is specific for either influenza A or influenza B viral nucleoproteins. If these nucleoproteins are present, a "half-sandwich" immunocomplex is formed. The membrane contains immobilized antibody to influenza A or influenza B nucleoproteins, respectively, which bind the "half sandwich" complex. Thus, in the presence of influenza nucleoproteins, a "whole sandwich" immunocomplex is formed and a visible, pink-colored line develops in the specimen zone of the test device. In the absence of an influenza antigen, a "sandwich" immunocomplex is not formed and a negative result is indicated. To serve as a procedural control, a pink-colored control line will always appear in the control zone of each strip regardless of the presence or absence of influenza A or influenza B nucleoproteins.

The provided text describes two influenza detection tests: the SASTM Influenza A Test (K041441) and the SASTM FluAlert A & B Test (K080380). The current submission (K132352) is primarily focused on updating the predicate devices for these tests to include sensitivity data for the H7N9 strain, rather than presenting a new clinical study with acceptance criteria for device performance. Therefore, a table of acceptance criteria and device performance as typically understood for a novel device's clinical study is not explicitly provided in this document.

The document primarily focuses on analytical sensitivity (Limit of Detection) and cross-reactivity for the H7N9 strain, rather than clinical performance metrics like sensitivity and specificity in patient cohorts.

Here's a breakdown of the information that can be extracted, addressing your points where possible:

Acceptance Criteria and Study Details for SASTM Influenza A Test and SASTM FluAlert A & B Test

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit acceptance criteria for clinical performance (e.g., sensitivity, specificity thresholds) are not provided in this document. The studies described are analytical studies for the H7N9 strain.

Analytical Performance for both devices (SASTM Influenza A Test and SASTM FluAlert A & B Test) for H7N9:

Note on Clinical Performance: The document explicitly states: "Performance characteristics for detecting the 2013 H7N9 influenza virus from human specimens have not been established." and "Although this test has been shown to detect the 2013 H7N9 from a cultured isolate, the performance characteristics of this test with clinical specimens that are positive for the 2013 H7N9 influenza virus have not been established." This indicates that the presented data is entirely analytical, not clinical.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The test sets for the analytical sensitivity studies consisted of serial dilutions of cultured viral strains. The exact number of replicates for each dilution is not specified, but the results for the Limit of Detection are provided. For the cross-reactivity study, various cultured viral strains were tested at specific concentrations. The exact number of specimens (or "samples") is not individually quantified beyond the listed strains and their concentrations.
• Data Provenance: The viral strains used (e.g., A/Anhui/1/2013 H7N9, various H1N1, H3N2, Influenza B strains) were obtained from ATCC and the CDC. The data is prospective in the sense that the experiments were conducted for this submission (analytical studies), but they used cultured isolates, not retrospective or prospective human clinical samples. The country of origin for the data is implied to be the United States (where SA Scientific is based and the CDC/ATCC are located).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not applicable as the studies are analytical (laboratory-based detection of cultured viruses), not clinical studies requiring expert ground truth interpretation of patient data. The "ground truth" here is the known presence and concentration of the virus in the cultured samples. The CDC provided the H7N9 strain with a known titer, though SA Scientific did not independently verify this titer.

4. Adjudication Method for the Test Set

• This information is not applicable as the studies are analytical and do not involve human interpretation or adjudication of clinical outcomes. The results are based on the visual detection of a pink line on the rapid immunoassay.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• This is not applicable. The device is an immunoassay (a rapid test strip), not an AI-powered diagnostic imaging or interpretive device. There is no AI component or human-reader performance improvement study described.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This is not applicable. The device is a rapid immunoassay, which is a standalone test in itself (it provides a visible result without external computational algorithms). There is no "algorithm" in the context of AI being tested. The human "in-the-loop" is simply reading the visual result.

7. The Type of Ground Truth Used

• The ground truth used was the known presence and concentration of specific cultured viral strains. For example, for the H7N9 strain, it was A/Anhui/1/2013, with a known titer provided by the CDC. This is a form of analytical ground truth derived from laboratory-established viral cultures.

8. The Sample Size for the Training Set

• This is not applicable. As a rapid immunoassay (not an AI model), there is no "training set" in the context of machine learning. The device's design and antibodies are developed through traditional biological and chemical means, not by training on a dataset.

9. How the Ground Truth for the Training Set Was Established

• This is not applicable for the reasons stated above (not an AI model).

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Remel Xpect® Flu A&B is a in vitro immunochromatographic test for the direct, qualitative detection of influenza A and influenza B viral antigens (nucleoprotein) from nasal wash, nasal swab, and throat swab specimens from symptomatic patients. The test is intended as an aid in the rapid diagnosis of influenza A and influenza B viral infections. A negative test is presumptive and it is recommended these results be confirmed by virus culture or an FDA-cleared influenza A and B molecular assay.

The Xpect® Flu A&B is a chromatographic immunoassay for the qualitative detection of influenza A and influenza B viral antigens. The test device incorporates separate membrane strips for influenza A and for influenza B. To perform the test, the patient specimen is diluted and added to the sample wells of the device. The mixture moves along the membranes by capillary action. If present, influenza A or B viral antigens in the patient sample bind anti-influenza A or B conjugated antibodies. A visible line forms as a complex of antibody-antigen-antibody coated colored particles is captured in the test region (T). Antibody coated colored particles not bound at the test line are later captured in the control region (C) containing goat anti-mouse antibody. A visible line will always appear in the control region indicating that the test is working properly. The presence of a control line combined with the absence of a visible test line is interpreted as a negative test result.

Here's an analysis of the provided text regarding the Remel Xpect® Flu A&B device, structured according to your request:

Acceptance Criteria and Study Details for Remel Xpect® Flu A&B

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on analytical sensitivity as the performance metric for this submission. While a single, overarching acceptance criterion isn't explicitly stated as a pass/fail threshold, the study's purpose is to demonstrate the device's ability to detect various influenza strains, including the newly added A/Anhui/1/2013 (H7N9). The "Detection Limit" column in the table below represents the reported device performance for each strain.

Note: The document explicitly states: "Although this test has been shown to detect the influenza A/California/04/2009 (H1N1) and A/Anhui/1/3012 (H7N9) viruses cultured from positive human specimens, the performance characteristics of this device with human specimens infected with these influenza A viruses have not been established." This indicates that the analytical sensitivity data presented here is for cultured viral strains, not directly from human clinical samples for the A/H1N1 and A/H7N9 strains mentioned.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The test set for analytical sensitivity consisted of 17 influenza strains (11 influenza A and 6 influenza B).
• Data Provenance: The data comes from laboratory testing of cultured viral strains. The country of origin for the data is not specified, but it is implied to be internal laboratory work conducted by Remel Inc. The study is a prospective experimental study in a controlled laboratory setting, not a retrospective analysis of clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Experts are not mentioned in the context of establishing ground truth for the analytical sensitivity test set. The ground truth for this type of test is typically based on the quantitated viral stock concentrations and the known presence/absence of the specific influenza strains.

4. Adjudication Method for the Test Set

Adjudication methods are not applicable and not mentioned for this analytical sensitivity study. The determination of a "positive endpoint" for each viral strain would be based on consistent visual readability of the test line by laboratory personnel following a defined protocol, not by expert consensus or adjudication of ambiguous results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done based on the provided text. The submission focuses on analytical sensitivity, not reader performance or human-AI interaction.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone study was done. The analytical sensitivity study evaluates the device's ability to detect different influenza strains at specified concentrations without human interpretation variability being a primary variable. The Remel Xpect® Flu A&B is a visual read immunochromatographic test, meaning the "algorithm" is the biochemical reaction itself, and the "standalone" performance refers to its ability to react correctly to various concentrations of target analytes. While human visual interpretation is involved, the study assesses the inherent detection capability of the test.

7. The Type of Ground Truth Used

The ground truth used for the analytical sensitivity study is the known concentration (quantitation and titration) of well-characterized influenza viral strains. This is measured as TCID50/ml (50% tissue culture infectious dose) or CEID50/ml (50% chicken embryo infectious dose).

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device or study description. The Remel Xpect® Flu A&B is a chemical-biological immunoassay, not a machine learning or AI-driven diagnostic device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

As stated above, a training set is not applicable to this device. Therefore, no ground truth for a training set was established.

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The QuickVue Influenza Test allows for the rapid, qualitative detection of influenza type A and type B antigens directly from nasal swab, nasal aspirate, and nasal wash specimens. The test is intended for use as an aid in the rapid diagnosis of acute influenza virus infection. The test is not intended to detect influenza C antigens. Negative test results should be confirmed by cell culture; they do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

The QuickVue Influenza Test involves the extraction of influenza A and B viral antigens. The patient specimen is placed in the Extraction Reagent Tube, during which time the virus particles in the specimen are disrupted, exposing internal viral nucleoproteins. After extraction, the Test Strip is placed in the Extraction Reagent Tube where nucleoproteins in the specimen will react with the reagents in the Test Strip. If the extracted specimen contains influenza antigens, a pink-to-red Test Line along with a blue procedural Control Line will appear on the Test Strip indicating a positive result. If influenza type A or type B antigens are not present, or are present at very low levels, only a blue procedural Control Line will appear.

The provided text contains information about a 510(k) submission for the QuickVue® Influenza test. However, it does not contain acceptance criteria or detailed study results that would allow for a complete description as requested. The document primarily focuses on establishing substantial equivalence to a predicate device and includes a brief analytical study for H7N9 detection.

Here's an analysis based on the available information, noting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the given text. A typical 510(k) summary for a diagnostic test would include sensitivity, specificity, and potentially positive and negative predictive values, along with their acceptance criteria. The document only mentions a "minimum detectable level" for H7N9.

2. Sample Size Used for the Test Set and Data Provenance

The document describes an "analytical study" to assess the ability to detect H7N9 and establish the Limit of Detection (LoD). It does not specify a sample size for this analytical study.

• Sample Size for Test Set: Not explicitly stated for the analytical study mentioned.
• Data Provenance: Not specified, but given it's an "analytical study" focused on LoD, it typically involves prepared samples (e.g., spiked samples or known concentrations of virus) rather than patient specimens. The document doesn't mention a clinical study with patient samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For an analytical study establishing Limit of Detection, ground truth is typically established by the known concentration of the analyte in the prepared samples, not by expert review of test results. If a clinical study were performed (which is not described in detail here), expert-adjudicated ground truth might be relevant.

4. Adjudication Method for the Test Set

This information is not provided. Given that the described study is analytical to determine LoD, an adjudication method for test interpretation by multiple readers is not relevant. The result (presence/absence of a test line) is read directly from the test strip.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This is not applicable and not mentioned. The QuickVue® Influenza test is a visual, qualitative immunoassay designed for direct interpretation, not an AI-assisted diagnostic device where human readers interact with AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The QuickVue® Influenza test is a lateral flow immunoassay that requires human interpretation of visual lines for a positive or negative result. It does not involve an algorithm working independently.

7. The Type of Ground Truth Used

For the analytical study mentioned (LoD for H7N9), the ground truth would be based on the known concentration of the H7N9 virus in the prepared samples used to determine the detection limit.

• Type of Ground Truth: Known viral concentration (for the LoD study).

8. The Sample Size for the Training Set

This information is not provided. For a rapid immunoassay like the QuickVue® Influenza test, there isn't typically a "training set" in the machine learning sense. Assay parameters are optimized through biochemical development and analytical testing.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no mention of a "training set" in the context of an AI/machine learning algorithm for this device. For the development and optimization of such an immunoassay, the "ground truth" during development would be established through careful analytical studies using known positive and negative samples, and samples with known concentrations of the target analyte.

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The Sofia Influenza A+B FIA employs immunofluorescence to detect influenza A and influenza B viral nucleoprotein antigens in nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens taken directly from symptomatic patients. This qualitative test is intended for use as an aid in the rapid differential diagnosis of acute influenza A and influenza B viral infections. The test is not intended to detect influenza C antigens. A negative test is presumptive and it is recommended these results be confirmed by virus culture or FDA-cleared influenza A and B molecular assay. Negative results do not preclude influenza virus infections and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

Performance characteristics for influenza A and B were established during February through March 2011 when influenza viruses A/California/7/2009 (2009 H1N1), A/Perth/16/2009 (H3N2), and B/Brisbane/60/2008 (Victoria-Like) were the predominant influenza viruses in circulation according to the Morbidity and Mortality Weekly Report from the CDC entitled "Update: Influenza Activity--United States, 2010-2011 Season, and Composition of the 2011-2012 Influenza Vaccine". Performance characteristics may vary against other emerging influenza viruses.

If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Virus culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

The Sofia Influenza A+B FIA employs immunofluorescence technology that is used with the Sofia Analyzer to detect influenza virus nucleoproteins.

The Sofia Influenza A+B FIA is a lateral-flow immunoassay that uses monoclonal antibodies that are specific for influenza antigens and have no known cross-reactivity to normal flora or other known respiratory pathogens.

Nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens are used for this test. The patient specimen is placed in the Reagent Tube, during which time the virus particles in the specimen are disrupted, exposing internal viral nucleoproteins. After disruption, the specimen is dispensed into the cassette sample well. From the sample well, the specimen migrates through a test strip containing various unique chemical environments. If influenza viral antigen is present, they will be trapped in a specific location.

• Note: Depending upon the user's choice, the cassette is either placed inside of the Sofia Analyzer for automatically timed development (Walk Away Mode) or placed on the counter or bench top for a manually timed development and then placed into the Sofia Analyzer to be scanned (Read Now Mode).
  The Sofia Analyzer will scan the test strip and measure the fluorescent signal by processing the results using method-specific algorithms. The Sofia Analyzer will display the test results (Positive, Negative, or Invalid) on the screen. The results can also be automatically printed on an integrated printer if this option is selected.

Here's an analysis of the provided text regarding the Sofia® Influenza A+B FIA device:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The provided text describes one analytical study (for H7N9 detection) and refers to previously established performance characteristics for common influenza strains.

• H7N9 Study (Analytical): The sample size for this specific study is not explicitly stated. The study focuses on establishing the Limit of Detection (LoD).
• Previous Performance Characteristics (Clinical): The text mentions that performance characteristics for influenza A and B were established during February through March 2011 when specific influenza viruses were prevalent.
  • Data Provenance: The general context indicates this data would be from the United States, as it references the CDC's Morbidity and Mortality Weekly Report regarding influenza activity in the US.
  • Retrospective or Prospective: The phrasing "performance characteristics were established during February through March 2011" suggests prospective data collection during a specific influenza season. However, no details on how many patient samples were tested are provided in this summary.

3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications

The provided summary does not explicitly state the number of experts used or their qualifications for establishing ground truth for the test set that determined the original performance characteristics.

For the H7N9 analytical study, the nature of establishing "minimum detectable level" implies laboratory testing rather than expert-based ground truth on clinical samples.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for establishing the ground truth for the clinical test sets (both for the previously established performance and the H7N9 study).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human reader improvement with/without AI assistance. This device is an immunoassay and an analyzer, not an AI-powered diagnostic imaging tool. Therefore, an MRMC study as typically understood in AI/imaging would not be applicable.

6. Standalone (Algorithm Only) Performance

Yes, the device's performance, as described by the "minimum detectable level" for H7N9 and the "performance characteristics" established for other influenza strains, represents its standalone performance. The Sofia Analyzer processes the results using "method-specific algorithms" and displays "Positive, Negative, or Invalid" results. There is no human-in-the-loop component for interpreting the test outcome itself; the human operates the device and reads its output.

7. Type of Ground Truth Used

• H7N9 Analytical Study: The ground truth for the H7N9 study is based on a known concentration of H7N9 virus (Egg Infective Dose (EID)30/mL), which is a common method for establishing the Limit of Detection for in vitro diagnostic tests.
• Previous Performance Characteristics (Clinical): The intended use statement mentions that for negative results, it is "recommended these results be confirmed by virus culture or FDA-cleared influenza A and B molecular assay." This implies that the ground truth for the clinical performance characteristics (established in 2011) was likely based on confirmation by these more definitive laboratory methods.

8. Sample Size for the Training Set

The document does not provide any information about a "training set" or its sample size. This is an in vitro diagnostic device based on immunofluorescence with specific reagent antibodies and an analyzer using "method-specific algorithms." The development process for such a device would involve extensive analytical validation (e.g., sensitivity, specificity, cross-reactivity) rather than a "training set" in the context of machine learning.

9. How Ground Truth for Training Set Was Established

As no training set is mentioned in the context of machine learning, this question is not applicable based on the provided text. The "method-specific algorithms" in the Sofia Analyzer would have been developed and validated through internal R&D and analytical studies, not typically through a machine learning training process with a dedicated training set and labeled ground truth in the same way an AI imaging algorithm would be.

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The QuickVue Influenza A+B test allows for the rapid, qualitative detection of influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab, nasal aspirate, and nasal wash specimens. The test is intended for use as an aid in the rapid differential diagnosis of acute influenza type A and type B viral infections. The test is not intended to detect influenza C antigens. Negative results should be confirmed by cell culture; they do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

The QuickVue Influenza A+B test involves the extraction of influenza A and B viral antigens. The patient specimen is placed in the Extraction Reagent Tube, during which time the virus particles in the specimen are disrupted, exposing internal viral nucleoproteins. After extraction, the Test Strip is placed in the Extraction Reagent Tube where nucleoproteins in the specimen will react with the reagents in the Test Strip. If the extracted specimen contains influenza A or B antigens, a pink-to-red Test Line along with a blue procedural Control Line will appear on the Test Strip indicating a positive result. The Test Line for influenza A or B will develop at separate specified locations on the same Test Strip. If influenza A or B antigens are not present, or are present at very low levels, only the blue procedural Control Line will appear.

Here's a breakdown of the acceptance criteria and the study information derived from the provided text for the QuickVue® Influenza A+B test:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document primarily focuses on demonstrating substantial equivalence to a predicate device and includes only one specific analytical study result for a new influenza strain (H7N9). There are no explicitly stated acceptance criteria with numerical targets for clinical performance metrics (e.g., sensitivity, specificity) within this summary. Instead, the "Conclusion" states "The QuickVue Influenza A+B test is substantially equivalent with the current QuickVue Influenza A+B test," implying that its performance should be comparable to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The provided text only details one analytical study for H7N9 detection. It does not specify a separate "test set" in the context of clinical samples, nor does it provide details on the sample size for this analytical study beyond the reported Limit of Detection. The data provenance (country of origin, retrospective/prospective) is also not mentioned for this analytical study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. The provided text describes an analytical study for Limit of Detection (LoD), which typically involves laboratory measurements and does not require expert ground truth establishment in the same way clinical studies do.

4. Adjudication Method for the Test Set

Not applicable as there is no described clinical "test set" and no method for adjudicating results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Improvement with AI vs. Without AI Assistance

Not applicable. The QuickVue® Influenza A+B test is a rapid, qualitative immunological test, not an AI-assisted diagnostic device that would involve human readers and requiring an MRMC study to assess AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This refers to the performance of the device itself (the test strip and reagents) without human interpretation beyond reading the result. The QuickVue® Influenza A+B test is inherently a standalone device in this sense, as it produces visual results that are interpreted directly. The "Summary of Performance Data" details an analytical study of the device's ability to detect the H7N9 virus independently.

7. The Type of Ground Truth Used

For the analytical study concerning H7N9, the "ground truth" would be established by the known concentration of the H7N9 virus (7.90 x 10^6 EID50/mL) in the prepared samples, which is a laboratory standard rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. The QuickVue® Influenza A+B test is a lateral flow immunoassay, not a machine learning or AI-based device that would require a "training set" in the computational sense.

9. How the Ground Truth for the Training Set was Established

Not applicable for the same reasons as point 8.

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The OSOM® Influenza A&B Test is an in vitro diagnostic immunochromatographic assay intended for the qualitative detection of influenza A and influenza B viral nucleoprotein antigens from nasal swab specimens in symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and/or B viral infections. This test is not intended for the detection of influenza C viruses. A negative test is presumptive and it is recommended these results be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.

The OSOM® Influenza A&B Test consists of a test stick that separately detects influenza A and B. The test procedure requires the solubilization of the nucleoproteins from a swab by mixing the swab in Extraction Buffer. The test stick is then placed in the sample mixture, which then migrates along the membrane surface. If influenza A and/or B viral antigens are present in the sample, it will form a complex with mouse monoclonal IgG antibodies to Influenza A and/or B nucleoproteins conjugated to colloidal gold. The complex will then be bound by another mouse anti-influenza A and/or B antibody coated on the nitrocellulose membrane. A pink to purple control line must appear in the control region of the stick for results to be valid. The appearance of a second and possibly a third light pink to purple line will appear in the test line region indicating an A, B or A and B positive result.

The provided text describes an update to the package insert of the OSOM® Influenza A&B Test (K092633) to include additional analytical reactivity information for specific H3N2v Influenza A strains. It is not an original submission for a new device, but rather a modification to an already cleared device. As such, the information typically found in an initial 510(k) for device performance and clinical studies demonstrating efficacy for establishing acceptance criteria and proving they are met is largely absent in this document.

However, based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here is the ability of the OSOM® Influenza A&B Test to react with and detect specific influenza A strains. The stated performance is that the device does react with these strains.

Note: The document specifies that "the performance characteristics of this device with clinical specimens that are positive for these 2009 H1N1 and H3N2v influenza viruses have not been established." This indicates these results are from analytical reactivity studies, not clinical performance studies.

2. Sample Size Used for the Test Set and Data Provenance

The test set consisted of cultured strains of the H3N2v Influenza A virus. The specific sample size (i.e., number of replicates for each strain) is not provided.
The data provenance is from analytical testing (e.g., in vitro laboratory testing) of cultured strains of the H3N2v influenza A virus. The origin of the data is not explicitly stated as a country, but the strains themselves suggest a US origin (West Virginia, Pennsylvania, Minnesota, Kansas, Indiana). The study is retrospective in the sense that the strains were already cultured and tested.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable/provided in the document as the study described is an analytical reactivity study using cultured viral strains. The "ground truth" for the test set is the known presence and concentration of the specific influenza virus strains in the cultured samples.

4. Adjudication Method for the Test Set

This information is not applicable/provided as this was an analytical reactivity study, not a clinical study involving human interpretation of results requiring adjudication. The device's reaction (detectable or not) is a direct output.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done for this submission. The submission pertains to updating analytical reactivity information for an already cleared in vitro diagnostic device, not evaluating human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, a standalone performance evaluation was done. The OSOM® Influenza A&B Test is an immunochromatographic assay, which is a rapid diagnostic test that provides a visual result (appearance of a pink to purple line). Its performance in detecting the H3N2v strains was evaluated directly, without human interpretation in the loop beyond observing the presence or absence of the test line.

7. The Type of Ground Truth Used

The ground truth used was the known presence and estimated concentration (EID50/mL or TCID50/mL) of specific cultured influenza A viral strains, often provided by sources like the CDC. This is a form of analytical truth based on established viral culture and quantification methods.

8. The Sample Size for the Training Set

This information is not applicable/provided. The detailed analytical reactivity described is for the test set that demonstrates the device's updated capabilities. For an already cleared device, detailed training set information for its initial development and clearance (K092633) is not part of this specific submission to update labeling. The OSOM® Influenza A&B Test is a lateral flow immunoassay, not a machine learning algorithm, so the concept of a "training set" in the computational sense does not apply. If "training set" refers to samples used during the original development and optimization of the assay, that information is not present here.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/provided for the reasons stated in point 8.

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The ViraZyme® Influenza ID test is a direct specimen test indicated for use in the qualitative detection of both influenza types A and B virus from throat swab specimens. The ViraZyme® Influenza ID test may be used when a patient is suspected of having symptoms of an influenza-like illness. These symptoms can include, but are not limited to the following: fever of 38.5℃, sore throat, headache, myalgia, rhinitis, vomiting, chills, malaise, and cough. A positive ViraZyme® result would indicate the presence of influenza type A or B virus. A negative result is considered presumptive and should be confirmed by culture. The ViraZyme® Influenza ID test does not detect influenza C, and is indicated for in Vitro Diagnostic Use only.

The ViraZyme® Influenza ID Test for Influenza Types A and B Viruses is an endogenous viralencoded enzyme assay (EVEA) and is intended for use in the qualitative determination of influenza types A and B from throat swab specimens. The ViraZyme® Influenza ID Test is not intended for the detection of influenza C.

Influenza types A and B virus possess surface glycoproteins with neuraminidase activity, that hydrolyze substrates which contain alpha-ketosidically linked N-acetylneuraminic acid (Neu5Ac). A modified Neu5Ac molecule has been synthesized and coupled to a chromogen to produce the neuraminidase substrate. In the presence of influenza types A and B virus the chromogenic substrate is then cleaved by the action of viral neuraminidase, releasing a free chromogen. This free chromogen precipitates to produce a blue color. The blue precipitate is then concentrated and collected from the reaction mixture onto a filter device.

ViraZyme® Influenza ID Test: Acceptance Criteria and Performance

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria. However, it presents the clinical performance of the ViraZyme® Influenza ID Test against a reference method. Based on the reported results, we can infer the achieved performance metrics.

Note: The inferred "Acceptance Criteria" are based on the typical expectations for in vitro diagnostic tests used as screening tools, where high specificity is often prioritized to minimize false positives, and sensitivity is acceptable for a screening test that would be confirmed by a more definitive method. The 100% reproducibility is explicitly stated as demonstrating adequate performance across different environments.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: 157 throat swab specimens.
• Data Provenance: The data was collected from field sites across the United States during the 1995-96 influenza season (November 11, 1995 to March 29, 1996). This was a prospective study, as specimens were collected specifically for this evaluation.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not explicitly state the number of experts or their specific qualifications (e.g., number of years of experience). However, it mentions that the reference method involved "viral isolation and culture confirmation with monoclonal antibodies" which is a laboratory-based gold standard. This process would typically be performed and interpreted by trained laboratory personnel, likely microbiologists or virologists, with expertise in viral culture and identification.

4. Adjudication Method

The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). The ground truth was established by a single reference method: viral isolation and culture confirmation with monoclonal antibodies. There is no indication of multiple expert readings or a consensus process for the reference method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focuses solely on the standalone performance of the ViraZyme® Influenza ID Test compared to a laboratory reference method. There is no mention of human readers' performance with or without AI assistance, as this is an in-vitro diagnostic test, not an AI-assisted diagnostic tool for human interpretation.

6. Standalone Performance

Yes, a standalone performance study was done. The entire clinical evaluation described in the document assesses the ViraZyme® Influenza ID Test's performance (algorithm/assay only, without human-in-the-loop interpretation impacting the result) against the reference method. The reported sensitivity and specificity values are for the device's standalone performance.

7. Type of Ground Truth Used

The type of ground truth used was viral isolation and culture confirmation with monoclonal antibodies. This is considered a highly reliable and definitive method for identifying influenza viruses.

8. Sample Size for the Training Set

The document does not provide any information regarding a distinct training set sample size. The clinical study described in the document appears to be solely for validation/testing purposes. It's possible that the device's development involved internal studies or smaller pilot data not mentioned in this summary, but no details are provided.

9. How the Ground Truth for the Training Set Was Established

As no information regarding a separate training set is provided, there is no information on how its ground truth would have been established.

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